Page 5 - Brochure Hibergene
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  Instructions for Use
4. Intended Use
The HiberGene COVID-19 assay is a LAMP-based molecular diagnostic test for the detection of the SARS-CoV-2 virus in upper respiratory swab samples from patients with symptoms suggestive of COVID-19 infection. The test may be used in two different formats:
1. Direct Format – Testing of upper respiratory swabs in transport media without extraction has been shown to provide effective detection of samples containing high to moderate viral loads of SARS-CoV-2.
2. Extraction – Testing of upper respiratory swabs in transport media following extraction has been shown to provide effective detection of samples across a wide viral load range (Ct value range 14.8 – 34.6).
Recommended Testing Algorithm
A. For patients swabbed within 7 days of onset of possible COVID-19 symptoms, testing in direct format is recommended. Sensitivity of 86- 95% has been demonstrated for this cohort. Negative results for patients where clinical suspicion remains should be confirmed by retesting after extraction, using a fresh aliquot of primary sample.
B. For patients swabbed more than 7 days from onset of symptoms, patients with suspected pneumonia or serious respiratory complications, or where a higher level of sensitivity is required for initial testing, it is recommended to use the extraction method.
The intended end user is a trained laboratory/health professional. Users must have received training from the distributor/HiberGene staff prior to using the device.
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